Pharmaceutical Regulatory Expert
2 weeks ago
Job Overview:
This is an exciting opportunity to join a highly experienced team as a Senior Regulatory Affairs Associate in the APAC region.
- Prepare and manage submissions, including new licenses, renewals, variations, PSURs, DSURs, and post-approval changes.
- Lead preparation of documentation for health authority meetings on mature products.
- Liaise with Global Regulatory Leads, providing local and regional input.
- Submit all regulatory documentation to Health Authorities in a timely, compliant manner.
- Respond to health authority queries and manage preparation of answers to both basic and complex regulatory questions.
- Independently file CAT 1 and CAT 3 applications under TGA requirements.
- Biological or Medical Science degree or a related field. Postgraduate studies in Regulatory Affairs are a strong advantage.
- Minimum 3+ years' experience in a regulatory affairs role with a focus on pharmaceuticals.
- Strong knowledge of TGA requirements and regulatory frameworks.
- Understanding of GMP, GCP, and GLP principles.
- Strategic thinker with excellent communication and collaboration skills.
What You'll Gain:
- Opportunity to work in a dynamic team with a strong track record of success.
- Professional development and growth opportunities.
- Chance to make a meaningful contribution to the company's mission.
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